Healthcare Industry News:  cataract 

Biopharmaceuticals Ophthalmology FDA

 News Release - October 8, 2008

Akorn, Inc. Announces the FDA Approval of Akten(TM) Ophthalmic Gel 3.5%

LAKE FOREST, Ill.--(HSMN NewsFeed)--Akorn, Inc. (NASDAQ: AKRX ) today announced the FDA approval of NDA 22-221 for Akten™ Ophthalmic Gel 3.5%, a topical, ocular anesthetic formulation. The NDA was filed June 29, 2007 following the results from a randomized, placebo controlled, Phase III clinical trial in 209 subjects who met the primary endpoint in all three dosing arms (p<0.001). Akten™ is the first NDA ocular anesthetic approved by the FDA in four decades, and will be launched in October 2008.

Akten™ is a novel, unit dose, preservative free lidocaine gel product, stored at room temperature and intended to be used in any ocular procedure that requires a topical anesthetic agent. The estimated market size for Akten™ is approximately eleven million procedures annually. The major procedures include cataract surgery, refractive surgery, Lasik surgery, and intravitreal injection. Akorn has filed two United States patents and one International patent on the formulation and method of use of Akten™.

Abu Alam, Ph.D., Akorn’s Senior Vice President of New Business Development stated, “The robust data from the multi-center clinical trial with respect to rapid onset and extended duration of anesthesia will be ideally suited for many ophthalmic procedures in both hospital and office based surgical setting. We would like to thank Drs. Elias Reichel and Brandon Busbee, who collaborated with Akorn on the clinical trial design, execution of the protocol and the three patents filed.”

Arthur S. Przybyl, Akorn’s President and Chief Executive Officer stated, “This is a very important milestone in our Company’s history, because it represents our first internally developed NDA drug product. We expect Akten™ to become the standard of care whenever an ocular anesthetic is prescribed. Akten™ will be manufactured at our Somerset, NJ facility and will be marketed directly to hospitals and ophthalmologists with a targeted detail sales effort, by our 65 sales representatives.”

About Akorn, Inc.

Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company’s website at www.akorn.com.

Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.

Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock.

Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled "Cautionary Statement Regarding Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Other factors besides those listed there could also adversely affect our results.


Source: Akorn

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